The present invention pertains to a method and related device used to provide access from a non-sterile environment to a sterile environment. More specifically, the invention relates to a sterile technique used during a medical procedure, such as disease treatment and/or diagnosis, taking place in lumens within a body. Such endoluminal procedures may take place in vascular, gastrointestinal, air exchange lumens, or other like places within the body and often require passing a device through the lumen wall to access a sterile environment.
Generally, medical practitioners have practiced and refined sterile techniques to prevent microbial contamination when passing objects such as catheters, other surgical tools, hands, fingers, medications, and the like from a non-sterile environment to a sterile environment. Implementing a sterile technique requires that the objects themselves remain microbe-free when entering the sterile environment. Additionally, the opening between the non-sterile and sterile environments must remain impassable to microbes for a time period sufficient to allow completion of the medical procedure and closure of the breach between the environments.
For a number of medical procedures, these requirements are more readily met. Such medical procedures occur in areas of the body that easily can be kept clean, dry and free from contamination for extended time periods. Moreover, many medical procedures occur in environmentally controlled surgical arenas, thus facilitating a sterile technique.
Many currently-employed methods and devices focus on avoiding contamination at catheter insertion sites on the patient""s body. Some of these methods and devices may attempt to stabilize the catheter and to apply antiseptic solutions at the insertion site. Such devices may include an adhesive patch or seal that surrounds the catheter and affixes to the patient""s skin. Additionally, the devices may include a mechanism for feeding antiseptic solution between the skin and the patch or seal. Overall, these systems attempt to apply a sterile technique at the boundary between the atmosphere (the non-sterile environment) and a point of insertion on the patient""s body. However, the current systems are not suited for performing a sterile technique at intracorporeal sites, for example the boundary between a gastrointestinal lumen (non-sterile environment) and the inter-abdominal cavity (sterile environment).
Achieving a sterile technique for many intracorporeal sites can pose difficulties. For instance, keeping an area of the body clean, dry, and free from contamination presents significant challenges when the treatment area exists in a part of the body awash with microbe-rich body fluids. An endoluminal procedure presents such a challenge. During an endoluminal procedure, diagnostic or treatment devices pass through a lumen wall to access other areas within the body, for example, entering the inter-abdominal cavity from the gastrointestinal tract, as mentioned earlier. Because body lumens generally are microbe-rich environments, a significant risk of infection arises due to the potential for the lumen fluids to leak through the hole formed in the lumen wall and into the sterile environment. Such infection can cause serious illness, such as sepsis, and even death.
Successful implementation of a sterile technique also may prove difficult when treatment proceeds under less than ideal environmental conditions. For example, medical procedures and treatments often take place on a battlefield or during a rescue operation where controlling and sterilizing the surrounding environment may be nearly impossible.
The advantages and purpose of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages and purpose of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
To attain the advantages and in accordance with the purpose of the invention, as embodied and broadly described herein, the invention includes a device for performing a sterile technique. According to a preferred embodiment of the invention, the device includes an outer hollow member having a sharp distal end for penetrating a tissue that separates a sterile environment from a non-sterile environment. The outer hollow member also has a seal at its sharp distal end. The device further includes an inner hollow member disposed within the outer hollow member and axially moveable with respect to the outer hollow member. The inner hollow member also has a sharp distal end for penetrating the tissue and extending into the sterile environment.
In another preferred embodiment of the invention, the device includes a distal end capable of penetrating a boundary layer separating a non-sterile environment from a sterile environment and an inner hollow member moveably disposed within the outer hollow member. The inner hollow member includes a distal end adapted to extend past the outer hollow member distal end and into a sterile environment. The device further includes a compartment containing a reservoir of antiseptic solution, with the reservoir in selective fluid communication with the outer hollow member so that when the inner hollow member extends into the sterile environment, the antiseptic solution flows through the outer hollow member to create a sterile boundary.
The invention further includes a method of performing a sterile medical procedure by creating a sterile passage. A preferred method includes penetrating a tissue separating a sterile environment from a non-sterile environment with a sharpened distal end of an outer hollow member, with the distal end of the outer hollow member including a seal. The method further includes extending a sharpened distal end of an inner hollow member in an axial direction with respect to the outer hollow member and penetrating the seal and the tissue so that the distal end of the inner hollow member enters the sterile environment.
Another preferred method according to the present invention includes penetrating a non-sterile/sterile boundary with a distal end of an outer hollow member, and providing an inner hollow member that is moveably disposed within the outer hollow member. The method further includes extending a distal end of the inner hollow member past the outer hollow member distal end and into the sterile environment, and providing a compartment containing a reservoir of antiseptic solution and selectively establishing fluid communication between the reservoir and the outer hollow member such that during the extending step, the antiseptic solution flows through the outer hollow member to enable a sterile technique.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.